Aspirin 300mg Tablets
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Please read this leaflet carefully before you start to take this medicine.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has bee prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• Keep this leaflet; you may need to read it again.
IN THIS LEAFLET
1. What your medicine does and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
The usual doses are as follows:
Adults and children over 16 years
Take 1 to 3 tablets. Take a further 1 to 3 tablets every 4 hours if necessary.
Do not take more than 12 tablets in 24 hours.
Elderly
As for adults.
Children
Do not give to children under 16 years, unless on the advice of a doctor.
For prevention of blood clots
1 tablet once a day.
If you take more of your medicine than you should
If you take more than the recommended dose, please contact your doctor or nearest hospital immediately.
If you forget to take your medicine
If you forget to take a dose, do not worry. Take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
Aspirin is an analgesic (pain relieving), antipyretic (temperature reducing) and anti-inflammatory (inflammation reducing) drug.
Aspirin is used for the following:
• To give effective pain relief from headache, migraine, neuralgia (nerve pain), sore throat, period pains and toothache.
• To give symptomatic relief of flu and feverish colds.
• In the treatment of rheumatoid arthritis, muscle aches and pains, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), osteoarthritis and acute and chronic rheumatic conditions.
The tablets may also be used to prevent blood clots especially after a heart attack or in patients with unstable angina or reduced blood flow in the brain.
Do not take your medicine if:
• You are allergic to aspirin, or any other pain relieving anti-inflammatory medicines e.g. Non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates. You may have developed difficulty breathing, swelling of the lips or face, itchy skin or runny nose after taking them. The allergic reaction may be displayed as an asthma attack when you have taken any of these medicines
• You have nasal polyps associated with asthma
• You have, or have had in the past a stomach or duodenal ulcer, or indigestion
• You have a bleeding disorder such as haemophilia or are taking medicines to thin the blood
• You are pregnant, planning to become pregnant or breast-feeding
• You are allergic to any of the ingredients listed in section 6 of this leaflet
• You are a child under 16 years old
• You have severe heart failure
• You have severe kidney or liver impairment
Important warning:
There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor e.g. for Kawasaki's disease.
If the answer is yes to any of the above, please tell your doctor.
Take special care with your medicine
Always tell your doctor before using this medicine if you:
• suffer from tightness in the chest, asthma or allergies
• have kidney or liver problems (aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) can cause salt and water retention and kidney failure, especially in patients with pre-existing kidney problems)
• have a history of gastrointestinal disorders (regular stomach upsets)
• had any disorders affecting blood vessels in the brain
• have blood tests for thyroid problems (aspirin can interfere with results of some blood tests)
• have diabetes (high blood sugar)
• have glucose 6 phosphate dehydrogenase deficiency (G-6-PD), a rare disorder (taking aspirin may make you more likely to develop problems with red blood cells)
• have systemic lupus erythematosus (SLE) or other connective tissue disease
• are anaemic or suffer from gastrointestinal bleeding (may cause anaemia)
• have gout (high levels of uric acid in the blood causing attacks of arthritis)
• are due to have surgery. Aspirin should be stopped several days before surgery
• suffer from dehydration
• have received varicella (chickenpox) vaccination within the last 6 weeks
• are elderly as you are more prone to adverse effects
Taking other medicines
Do not drink alcohol while taking this medicine.
You should consult your doctor before taking this medicine if you are taking any of the following:
• medicines to prevent blood clotting (e.g. warfarin, heparin, ticlopidine, dipyridamole)
• medicines to lower blood sugar if you are a diabetic (e.g. insulin, sulphonylureas)
• medicines to treat gout (e.g. probenecid, sulfinpyrazone)
• medicines which make your urine more alkaline such as antacids and citrates
• medicines used as anti-depressants (e.g. SSRI's or Venlafaxine)
• medicines used as appetite suppressants (e.g. Sibutramine)
• medicines used as anti-asthma drugs (e.g. Zafirlukast)
• medicines which can cause hearing problems (e.g. Vancomycin)
• medication for heart problems or to lower blood pressure such as ACE inhibitors and calcium channel blockers
• medication containing corticosteroids or any pain-relieving or anti-inflammatory medicines - if taken with aspirin may increase the risk of bleeding or ulcers in the stomach
• Ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Methotrexate (medicine used for psoriasis, rheumatoid arthritis, Crohn's disease and some types of cancer)
• Diuretics (“water tablets”) such as spironolactone and furosemide
• Digoxin (medicine used for certain heart conditions)
• Phenytoin and sodium valproate (medicines used to treat epilepsy)
• Acetazolamide (used to treat build up of pressure in the eyes)
• Metoclopramide and domperidone (to prevent sickness)
• Mifepristone (to induce abortion)
• Sulphonamides (aspirin may increase their toxicity)
• Varicella (chickenpox) vaccine. Aspirin should be avoided for 6 weeks after vaccination
• Ginkgo biloba (possible increase in risk of bleeding)
Laboratory investigations - aspirin may interfere with some laboratory tests such as urine 5-hydroxyindoleacetic acid determinations and copper sulphate urine sugar tests.
Pregnancy and breast-feeding
Do not take this medicine without first consulting with your doctor if you are pregnant, planning to become pregnant or are breast-feeding.
As with other medicines aspirin can cause side effects.
The following side effects are rare. Stop your medicine immediately and contact you doctor if the following side effects occur:
• allergic symptoms such as difficulty in breathing, large or itchy wheals on the skin, attacks of sneezing and itching eyes
• severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Lyells syndrome) or severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome)
• bleeding on the brain (sudden severe headache, fit, changes in vision, speaking, understanding or coordination, weakness in an arm or leg
• salicylism - if you take large doses for a long time you may develop symptoms of salicylism, these include: dizziness, ringing or buzzing in the ear, deafness, sweating, feeling or being sick, headache and confusion
• difficulty breathing
• stomach ulcers, severe stomach pain or bleeding which can be severe (you may develop bloody or black tarry stools, and vomit blood - looks like coffee grounds)
• hepatitis (inflammation of the liver causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles)
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common: may affect up to 1 in 10 people
• Increase in the number of nose bleeds, longer bleeding time or you notice that you bruise more easily or have more infections than usual
• Indigestion
Uncommon: may affect up to 1 in 100 people
• Runny nose
• Itchy skin rash caused by allergic reaction - pale or red irregular raised patches with severe itching (hives)
Rare: may affect up to 1 in 1,000 people
• Anaemia, changes in numbers and types of blood cells and enzymes seen in blood tests
• Difficulty breathing or wheezing, worsening of asthma
• Heavy periods
• Irregular red patches on the skin of the hands and arms (erythema multiforme)
• Disorder characterised by blood spots, bruising and discolouring to skin (Purpura)
• Bleeding in the skin, mucous membranes
• Red tender lumps developing under the skin (Erythema nodosum)
Not known: frequency cannot be estimated from the available data
• Gout (high levels of uric acid in the blood) - causing crystals to deposit in joints of hands/feet causing pain (Hyperuricemia)
• Nosebleeds, bleeding of the gums, which may be prolonged. (Please advise doctor or dentist if surgery is planned)
• Reduction of red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia), reduction in red blood cells which cause pale yellow skin and weakness or breathlessness (haemolytic anaemia), blood disorder resulting in impaired blood clotting leading to an increased risk of bleeding, reduced number in red and white blood cells, blood loss, elevated blood enzymes levels (as seen in blood test)
• Headache
• Feeling of dizziness or spinning
• Hearing loss, ringing or buzzing in the ears
• Liver problems
• Reduced kidney function
If you experience any of the above or are concerned about anything or you notice anything unusual contact your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
This medicine should not be used after the expiry date stated on the pack.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store this medicine below 25°C in a dry place in the original pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What your medicine looks like
Aspirin 300mg Tablets BP are white, round, biconvex tablets.
They are available in the following pack sizes: 16, 32 and 100 tablets.
What your medicine contains
Aspirin 300mg Tablets BP contains 300mg aspirin BP.
The tablets also contain the inactive ingredient maize starch.
The holder of this product licence and company responsible for release of this medicine is
Athlone Pharmaceuticals Ltd., Ballymurray, Co. Roscommon.
Distributed by
Kent Pharmaceuticals Ltd., Wotton Road, Ashford, Kent TN23 6LL, U.K.
PL 30464/0005
This leaflet was revised in July 2013.
You should take your medicine as directed by your doctor. The pharmacist's label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.
Do not exceed the stated amount. The tablets should be taken with a drink of water.
Aspirin may be taken with food to help avoid stomach upset.
Avoid alcohol whilst taking this medicine.
° CP.ASP.300T.V1P4